Teleflex, and Arrow International, Recall Pressure Injectable Catheter Kits for Mislabeling
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Recalled Product
- Product Names: Pressure Injectable Central Venous Catheters
- Product Codes: See table below
- Distribution Dates: August 30, 2022 to June 9, 2023
- Devices Recalled in the U.S.: 1,905
- Date Initiated by Firm: August 10, 2023
Device Use
The Teleflex and Arrow International Pressure Injectable Catheter Kits allow health care providers access to a patient’s central cardiovascular system, which connects the heart and veins. The kits may be used short-term (less than 30 days) for patients with conditions that require frequent injections or blood draws. With the kit, a health care provider can sample blood, monitor blood pressure, or administer fluids, medications, or chemotherapy.
Reason for Recall
Teleflex, and its subsidiary Arrow International, are recalling the below listed Pressure Injectable Catheter Kits due to mislabeling regarding the presence of chlorhexidine in these products. The product code and product name are incorrectly listed as non-coated on the lids of the affected Pressure Injectable Catheter Kits. However, the banner card correctly lists the product code and product name as chlorohexidine coated.
The names of the devices and associated product codes being recalled:
| Type of Action | Recall Notice |
|---|---|
| Teleflex Reference | EIF-000543 |
| Commercial Name | Product Codes | Batch/Lot |
|---|---|---|
| Pressure Injectable One-Lumen PICC | CDC-05541-HPK1A | 143F22J0617 |
| Pressure Injectable Two-Lumen PICC pre-loaded with Arrow VPS Stylet | CDC-35552-VPS | 13F22EO359 |
| Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC | CDC-42854-XPCN1A | 33F23B0723 |
| Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with Arrow VPS Precision Stylet | CDC-45552-VPS2 | 33F23B0781 |
| Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC | CDC-45854-P1A | 13F22L0806 |
| Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded with Arrow VPS TipTracker Stylet | CDC-45563-TTS | 13F22G0508 |
People who inadvertently use these kits may have serious adverse health effects, such as allergic reactions including itching, redness, skin changes, hives, dizziness, drop in blood pressure, difficulty breathing, and anaphylaxis which could lead to death if they are allergic to chlorohexidine.
There have been 16 reported incidents associated with this issue. There have been no reports of injuries or deaths related to this issue.
Who May be Affected
- People who receive care with the Pressure Injectable Catheter Kits.
- People with hypersensitivity or allergy to chlorhexidine.
- Health care professionals who provide care with the ARROW Pressure Injectable Catheter Kits
What to Do
On August 10, 2023, Teleflex and Arrow International sent an Urgent Medical Device Recall letter to medical facilities and distributors that included the following recommended actions:
For Medical Facilities
- Immediately:
- Check inventory for product within the scope of this recall.
- Stop using and distributing affected product.
- Quarantine affected product.
- Mark the applicable checkbox (affected product or no affected product) on the acknowledgement form included with the letter. Fax the form to 1-855-419-8507 to Attn: Customer Service or email the form to recalls@teleflex.com.
- If you have affected product, a customer service representative will contact you with a Return Goods Authorization (RGA) number and will provide instructions for the return of affected products to Teleflex. Teleflex (or the local dealer) will issue a credit note upon receipt of the returned affected product.
For Distributors
- Provide a copy of the Urgent Medical Device Recall letter to all customers who have received impacted product. Each customer must complete the acknowledgement form and return it to the distributor.
- Immediately stop use and distribution of, and immediately quarantine, the affected product. Then return all product in scope.
- Confirm to Teleflex that field activities outlined have been completed.
- After completing actions, forward the completed acknowledgement form to recalls@teleflex.com.
- Ensure you only list batch numbers in scope of the recall notice when completing the form.
- If product was distributed outside of the country, notify Teleflex Customer Service.
Contact Information
Customers with questions should contact Teleflex and its subsidiary Arrow International Customer Service by calling 1-866-396-2111 or emailing recalls@teleflex.com.
Additional Resources:
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.